check_circleStudy Completed

Magnetic Resonance Imaging, Magnetic Resonance Angiography

Bayer Identifier:

14823

ClinicalTrials.gov Identifier:

NCT01095081

EudraCT Number:

Not Available

EU CT Number:

Not Available
GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected patients

Trial purpose

Prospective, non-interventional, multi-center study. The observation period for each subject covers the treatment period with Gadovist®. For each patient, the treating physician or nurse documents demographics, medical data, safety parameters and treatment signs and symptoms at the visit. Patients with severe renal impairment will be followed-up after 3 month by phone call from the investigator if in line with routine practice. Data audit/monitoring by source data verification will be done in a subset of sites and patients

Key Participants Requirements

Sex

Both

Age

0 - N/A
  • - Patients undergoing contrast enhanced Magnetic Resonance Imaging with Gadobutrol (Gadovist).
  • - There are no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics (hypersensitivity to the active substance or to any of the excipients) and the warnings.

Trial summary

Enrollment Goal
23775
Trial Dates
July 2010 - April 2013
Phase
N/A
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Taiwan
Completed
Many Locations, Poland
Completed
Many Locations, South Africa
Completed
Many Locations, Italy
Completed
Many Locations, Hungary
Completed
Many Locations, Kazakhstan
Completed
Many Locations, Korea, Republic Of
Completed
Many Locations, Hong Kong
Completed
Many Locations, Russia
Completed
Many Locations, China
Completed
Many Locations, Thailand
Completed
Many Locations, Bosnia And Herzegovina
Completed
Many Locations, France
Completed
Many Locations, Greece
Completed
Many Locations, Vietnam
Completed
Many Locations, Czech Republic
Completed
Many Locations, Spain
Completed
Many Locations, Canada
Completed
Many Locations, Germany
Completed
Many Locations, Kyrgyzstan

Primary Outcome

  • Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups
    date_rangeTime Frame:
    1 day
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Analysis of Adverse Event Collection rates according to age, gender, concomitant diseases and risk factors, dose administered.
    date_rangeTime Frame:
    1 day
    enhanced_encryption
    Safety Issue:
    yes

Trial design

GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected patients
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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